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Event Details


Products Used in Early Phase IND Studies

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Who should attend?

Regulatory Affairs Personnel who Coordinate Activities for the CMC Sections of Submissions QA/QC Personnel who Need to Plan Work on Early Stage Material R & D Personnel who Will Contribute data to CMC Sections Project Managers for Product Development Studies Quality Systems Auditors Consultants


How it may be integrated with the recommendations of the guidance
documents on CMC requirements.

Areas Covered in the Session:
Discussion of the elements found in the guidance document for Phase 1
What to do at really early stages
What about special IND studies?
What about preclinical studies?

Who Will Benefit:
Regulatory Affairs personnel who coordinate activities for the CMC
sections of submissions
QA/QC personnel who need to plan work on early stage material
R & D personnel who will contribute data to CMC sections
Project managers for product development studies
Quality systems auditors

Speaker Profile:
Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP
BioTechnology LLC, a consulting firm that works in the areas covered
by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has
over 30 years of experience in supervising quality control laboratories,
including an animal testing facility, and in performing GLP and GMP
audits of internal and external testing laboratories .

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407


One Dial-in One Attendee Price: $150.00


Event Manager

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